Trial Outcomes & Findings for Intravitreal Aflibercept Injection in Vision Impairment Due to DME (NCT NCT01331681)
NCT ID: NCT01331681
Last Updated: 2023-11-27
Results Overview
Visual function of the study eye was assessed using the ETDRS protocol. A higher score represents better functioning.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
406 participants
Primary outcome timeframe
Baseline up to Week 52
Results posted on
2023-11-27
Participant Flow
Participants with diabetic macular edema (DME) secondary to diabetes mellitus involving the center of the macula in the study eye could participate in the study. The study was conducted at 73 study centers in Japan, European Countries and Australia between 09 May 2011(first participant first visit) and 30 Mar 2015 (last participant last visit).
Of 604 participants who were screened for inclusion in the study, 406 were randomized, and 404 received treatment.
Participant milestones
| Measure |
Intravitreal Aflibercept Injection 2Q4
Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF \[vascular endothelial growth factor\] Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
|
Intravitreal Aflibercept Injection 2Q8
Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).
|
Macular Laser Photocoagulation (Control)
Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
136
|
135
|
135
|
|
Overall Study
Participants Received Treatment
|
136
|
135
|
133
|
|
Overall Study
Completed Week 52
|
125
|
121
|
115
|
|
Overall Study
Completed Week 100
|
115
|
110
|
105
|
|
Overall Study
Completed Week 148
|
101
|
101
|
100
|
|
Overall Study
COMPLETED
|
101
|
101
|
100
|
|
Overall Study
NOT COMPLETED
|
35
|
34
|
35
|
Reasons for withdrawal
| Measure |
Intravitreal Aflibercept Injection 2Q4
Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF \[vascular endothelial growth factor\] Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
|
Intravitreal Aflibercept Injection 2Q8
Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).
|
Macular Laser Photocoagulation (Control)
Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
10
|
13
|
10
|
|
Overall Study
Death
|
6
|
6
|
2
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
12
|
8
|
15
|
|
Overall Study
Protocol Violation
|
1
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
4
|
1
|
|
Overall Study
Physician Decision
|
2
|
0
|
4
|
|
Overall Study
Therapeutic procedure required
|
1
|
0
|
0
|
|
Overall Study
Sponsor decision
|
1
|
1
|
0
|
|
Overall Study
Switching to other therapy
|
0
|
0
|
1
|
|
Overall Study
Not Received Study Treatment
|
0
|
0
|
2
|
Baseline Characteristics
Intravitreal Aflibercept Injection in Vision Impairment Due to DME
Baseline characteristics by cohort
| Measure |
Intravitreal Aflibercept Injection 2Q4
n=136 Participants
Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
|
Intravitreal Aflibercept Injection 2Q8
n=135 Participants
Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).
|
Control
n=133 Participants
Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks.
|
Total
n=404 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
62.6 Years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
64.2 Years
STANDARD_DEVIATION 7.8 • n=7 Participants
|
63.9 Years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
63.6 Years
STANDARD_DEVIATION 8.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
154 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
83 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
250 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 52Population: Full analysis set (FAS) included all randomized participants who received any study treatment, had a baseline measurement of BCVA, and had at least 1 post-baseline assessment of BCVA.
Visual function of the study eye was assessed using the ETDRS protocol. A higher score represents better functioning.
Outcome measures
| Measure |
Intravitreal Aflibercept Injection 2Q4
n=136 Participants
Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
|
Intravitreal Aflibercept Injection 2Q8
n=135 Participants
Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).
|
Control
n=132 Participants
Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in BCVA (Best Corrected Visual Acuity) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 - Last Observation Carried Forward (LOCF)
|
10.5 Letters correctly read
Standard Deviation 9.55
|
10.7 Letters correctly read
Standard Deviation 9.32
|
1.2 Letters correctly read
Standard Deviation 10.65
|
SECONDARY outcome
Timeframe: Baseline up to Week 52Population: FAS.
Visual function of the study eye was assessed using the ETDRS protocol. A higher score represents better functioning.
Outcome measures
| Measure |
Intravitreal Aflibercept Injection 2Q4
n=136 Participants
Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
|
Intravitreal Aflibercept Injection 2Q8
n=135 Participants
Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).
|
Control
n=132 Participants
Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks.
|
|---|---|---|---|
|
Percentage of Participants Who Gained at Least 10 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF
|
54.4 Percentage of participants
|
53.3 Percentage of participants
|
25.8 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 52Population: FAS.
Visual function of the study eye was assessed using the ETDRS protocol. A higher score represents better functioning.
Outcome measures
| Measure |
Intravitreal Aflibercept Injection 2Q4
n=136 Participants
Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
|
Intravitreal Aflibercept Injection 2Q8
n=135 Participants
Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).
|
Control
n=132 Participants
Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks.
|
|---|---|---|---|
|
Percentage of Participants Who Gained at Least 15 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF
|
32.4 Percentage of participants
|
33.3 Percentage of participants
|
9.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 52Population: Full-Analysis Set with assessment for this outcome measure.
Baseline ETDRS DRSS: None (level 10); Mild to moderate nonproliferative DR (levels 14, 15, 20, 35, and 43); Moderately severe/severe nonproliferative DR (levels 47 and 53); Mild/moderate/high-risk/advanced proliferative DR (levels 61, 65, 71,75, 81, and 85)
Outcome measures
| Measure |
Intravitreal Aflibercept Injection 2Q4
n=81 Participants
Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
|
Intravitreal Aflibercept Injection 2Q8
n=83 Participants
Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).
|
Control
n=80 Participants
Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks.
|
|---|---|---|---|
|
Percentage of Participants With a ≥2-step Improvement From Baseline in the ETDRS DRSS (Diabetic Retinopathy Severity Score) as Assessed by FP (Fundus Photography) at Week 52 - LOCF
|
33.3 Percentage of participants
|
27.7 Percentage of participants
|
7.5 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 52Population: Full-Analysis Set with assessment for this outcome measure.
Outcome measures
| Measure |
Intravitreal Aflibercept Injection 2Q4
n=135 Participants
Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
|
Intravitreal Aflibercept Injection 2Q8
n=135 Participants
Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).
|
Control
n=132 Participants
Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Central Retinal Thickness (CRT) at Week 52 as Assessed on Optical Coherence Tomography (OCT) - LOCF
|
-195.0 micrometer
Standard Deviation 146.59
|
-192.4 micrometer
Standard Deviation 149.89
|
-66.2 micrometer
Standard Deviation 138.99
|
SECONDARY outcome
Timeframe: Baseline up to Week 52Population: Full-Analysis Set with assessment for this outcome measure.
The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales that are all scored from 0-100. Near activities are defined as reading ordinary print in newspapers, performing work or hobbies requiring near vision, or finding something on a crowded shelf.
Outcome measures
| Measure |
Intravitreal Aflibercept Injection 2Q4
n=128 Participants
Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
|
Intravitreal Aflibercept Injection 2Q8
n=134 Participants
Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).
|
Control
n=120 Participants
Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Near Activities Subscale at Week 52 - LOCF
|
5.73 Scores on a scale
Standard Deviation 18.932
|
5.29 Scores on a scale
Standard Deviation 19.058
|
3.54 Scores on a scale
Standard Deviation 16.768
|
SECONDARY outcome
Timeframe: Baseline up to Week 52Population: Full-Analysis Set with assessment for this outcome measure.
The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales that are all scored from 0-100. Distance activities are defined as reading street signs or names on stores, and going down stairs, steps, or curbs.
Outcome measures
| Measure |
Intravitreal Aflibercept Injection 2Q4
n=128 Participants
Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
|
Intravitreal Aflibercept Injection 2Q8
n=134 Participants
Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).
|
Control
n=120 Participants
Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Distance Activities Subscale at Week 52 - LOCF
|
0.94 Scores on a scale
Standard Deviation 16.487
|
5.32 Scores on a scale
Standard Deviation 18.475
|
2.26 Scores on a scale
Standard Deviation 15.923
|
Adverse Events
Intravitreal Aflibercept Injection 2Q4
Serious events: 63 serious events
Other events: 117 other events
Deaths: 0 deaths
Intravitreal Aflibercept Injection 2Q8
Serious events: 60 serious events
Other events: 122 other events
Deaths: 0 deaths
Macular Laser Photocoagulation (Control)
Serious events: 51 serious events
Other events: 113 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intravitreal Aflibercept Injection 2Q4
n=136 participants at risk
Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
|
Intravitreal Aflibercept Injection 2Q8
n=135 participants at risk
Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).
|
Macular Laser Photocoagulation (Control)
n=133 participants at risk
Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks. During year 3 laser patients could receive IAI as needed (PRN) .
|
|---|---|---|---|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Cardiac disorders
Bundle branch block right
|
0.74%
1/136 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Cardiac disorders
Cardiac failure
|
0.74%
1/136 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
1.5%
2/135 • Number of events 2 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
1.5%
2/133 • Number of events 2 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.75%
1/133 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Blood and lymphatic system disorders
Immune thrombocytopenic purpura
|
0.74%
1/136 • Number of events 2 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.75%
1/133 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Cardiac disorders
Acute myocardial infarction
|
1.5%
2/136 • Number of events 2 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
2.3%
3/133 • Number of events 3 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Cardiac disorders
Arrhythmia
|
0.74%
1/136 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Cardiac disorders
Cardiac failure acute
|
0.74%
1/136 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.75%
1/133 • Number of events 2 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Cardiac disorders
Cardiac sarcoidosis
|
0.74%
1/136 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Cardiac disorders
Cardiac valve disease
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Cardiac disorders
Coronary artery disease
|
1.5%
2/136 • Number of events 3 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.75%
1/133 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Cardiac disorders
Coronary artery stenosis
|
1.5%
2/136 • Number of events 2 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Cardiac disorders
Hypertensive heart disease
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.75%
1/133 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Cardiac disorders
Left ventricular failure
|
0.74%
1/136 • Number of events 2 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Cardiac disorders
Mitral valve stenosis
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.75%
1/133 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Cardiac disorders
Myocardial infarction
|
2.9%
4/136 • Number of events 4 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.75%
1/133 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Cardiac disorders
Myocardial ischaemia
|
0.74%
1/136 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.75%
1/133 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Cardiac disorders
Ventricular tachycardia
|
0.74%
1/136 • Number of events 2 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.75%
1/133 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Endocrine disorders
Toxic nodular goitre
|
0.74%
1/136 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Eye disorders
Cataract
|
3.7%
5/136 • Number of events 8 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
5.2%
7/135 • Number of events 11 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
1.5%
2/133 • Number of events 2 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Eye disorders
Cataract subcapsular
|
0.74%
1/136 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
1.5%
2/135 • Number of events 2 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
1.5%
2/133 • Number of events 2 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Eye disorders
Iridocyclitis
|
0.74%
1/136 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Eye disorders
Macular degeneration
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.75%
1/133 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Eye disorders
Macular fibrosis
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Eye disorders
Macular hole
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Eye disorders
Optic atrophy
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.75%
1/133 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Eye disorders
Posterior capsule opacification
|
0.74%
1/136 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Eye disorders
Retinal artery occlusion
|
0.74%
1/136 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Eye disorders
Retinal detachment
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
1.5%
2/135 • Number of events 2 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.75%
1/133 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Eye disorders
Retinal exudates
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.75%
1/133 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Eye disorders
Retinal neovascularisation
|
0.74%
1/136 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
2.3%
3/133 • Number of events 4 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Eye disorders
Retinal vascular disorder
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.75%
1/133 • Number of events 2 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Eye disorders
Retinopathy proliferative
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.75%
1/133 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Eye disorders
Vitreous haemorrhage
|
2.9%
4/136 • Number of events 5 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
1.5%
2/133 • Number of events 4 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.74%
1/136 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.74%
1/136 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.75%
1/133 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
1.5%
2/135 • Number of events 2 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.74%
1/136 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.74%
1/136 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.74%
1/136 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Gastrointestinal disorders
Reflux gastritis
|
0.74%
1/136 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
General disorders
Chest pain
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.75%
1/133 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
General disorders
Death
|
0.74%
1/136 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
General disorders
Device failure
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.75%
1/133 • Number of events 2 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
General disorders
Generalised oedema
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 2 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
General disorders
Injection site injury
|
0.74%
1/136 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
General disorders
Oedema peripheral
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Infections and infestations
Cellulitis
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
1.5%
2/135 • Number of events 2 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
1.5%
2/133 • Number of events 2 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Infections and infestations
Cholecystitis infective
|
0.74%
1/136 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Infections and infestations
Endophthalmitis
|
0.74%
1/136 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.75%
1/133 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Infections and infestations
Gangrene
|
0.74%
1/136 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Infections and infestations
Infected dermal cyst
|
0.74%
1/136 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.75%
1/133 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.75%
1/133 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Infections and infestations
Pilonidal cyst
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Infections and infestations
Pneumonia
|
0.74%
1/136 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
2.2%
3/135 • Number of events 3 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Infections and infestations
Salmonellosis
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Infections and infestations
Sepsis
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.75%
1/133 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.75%
1/133 • Number of events 2 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Injury, poisoning and procedural complications
Brain herniation
|
0.74%
1/136 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.75%
1/133 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.74%
1/136 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Injury, poisoning and procedural complications
Fracture
|
0.74%
1/136 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.75%
1/133 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
2.2%
3/136 • Number of events 3 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.74%
1/136 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.75%
1/133 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.74%
1/136 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.75%
1/133 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Injury, poisoning and procedural complications
Traumatic arthrosis
|
0.74%
1/136 • Number of events 2 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Injury, poisoning and procedural complications
Traumatic fracture
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.75%
1/133 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Investigations
Catheterisation cardiac
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Investigations
Electrocardiogram ST segment depression
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.75%
1/133 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Investigations
Visual acuity tests abnormal
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.75%
1/133 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.74%
1/136 • Number of events 2 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
1.5%
2/135 • Number of events 2 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.75%
1/133 • Number of events 2 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.74%
1/136 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
1.5%
2/135 • Number of events 2 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
1.5%
2/133 • Number of events 2 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.75%
1/133 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Metabolism and nutrition disorders
Ketoacidosis
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.74%
1/136 • Number of events 2 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.74%
1/136 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.74%
1/136 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.75%
1/133 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
1.5%
2/133 • Number of events 2 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Musculoskeletal and connective tissue disorders
Metatarsalgia
|
0.74%
1/136 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.75%
1/133 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.5%
2/136 • Number of events 2 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.75%
1/133 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 2 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.75%
1/133 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.75%
1/133 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.75%
1/133 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis stenosans
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal neoplasm
|
0.74%
1/136 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anaplastic astrocytoma
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.74%
1/136 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.74%
1/136 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.75%
1/133 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.74%
1/136 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.75%
1/133 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.74%
1/136 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.75%
1/133 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.75%
1/133 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma stage IV
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer stage I
|
0.74%
1/136 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer stage III
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
1.5%
2/136 • Number of events 2 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.75%
1/133 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.74%
1/136 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Nervous system disorders
Brain stem infarction
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.75%
1/133 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Nervous system disorders
Cauda equina syndrome
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.75%
1/133 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Nervous system disorders
Cerebral atrophy
|
0.74%
1/136 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Nervous system disorders
Cerebral haematoma
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.74%
1/136 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Nervous system disorders
Cerebrovascular accident
|
2.9%
4/136 • Number of events 4 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.75%
1/133 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Nervous system disorders
Ischaemic stroke
|
1.5%
2/136 • Number of events 2 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.75%
1/133 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Nervous system disorders
Nerve compression
|
0.74%
1/136 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Nervous system disorders
Peripheral sensorimotor neuropathy
|
0.74%
1/136 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Nervous system disorders
Syncope
|
0.74%
1/136 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Psychiatric disorders
Depression
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.75%
1/133 • Number of events 2 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.75%
1/133 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.74%
1/136 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.75%
1/133 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.74%
1/136 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.75%
1/133 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Renal and urinary disorders
Renal failure
|
0.74%
1/136 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
1.5%
2/135 • Number of events 2 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 2 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.75%
1/133 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
1.5%
2/133 • Number of events 2 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.74%
1/136 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.75%
1/133 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.75%
1/133 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.74%
1/136 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.74%
1/136 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.74%
1/136 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.74%
1/136 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.74%
1/136 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.74%
1/136 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.74%
1/136 • Number of events 2 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
1.5%
2/133 • Number of events 2 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
1.5%
2/133 • Number of events 3 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
1.5%
2/133 • Number of events 2 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Surgical and medical procedures
Arteriovenous shunt operation
|
0.74%
1/136 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Surgical and medical procedures
Cataract operation
|
2.2%
3/136 • Number of events 3 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
1.5%
2/133 • Number of events 3 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Surgical and medical procedures
Osteosynthesis
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.75%
1/133 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Surgical and medical procedures
Peripheral artery bypass
|
0.74%
1/136 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.75%
1/133 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Surgical and medical procedures
Radical prostatectomy
|
0.74%
1/136 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Surgical and medical procedures
Transurethral prostatectomy
|
0.74%
1/136 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Surgical and medical procedures
Vitrectomy
|
0.74%
1/136 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Vascular disorders
Arterial haemorrhage
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.75%
1/133 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Vascular disorders
Deep vein thrombosis
|
0.74%
1/136 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Vascular disorders
Hypertension
|
0.74%
1/136 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/133 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.75%
1/133 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.74%
1/136 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
1.5%
2/135 • Number of events 2 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
2.3%
3/133 • Number of events 3 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Vascular disorders
Peripheral artery stenosis
|
0.74%
1/136 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.00%
0/135 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.75%
1/133 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/136 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.74%
1/135 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.75%
1/133 • Number of events 3 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
Other adverse events
| Measure |
Intravitreal Aflibercept Injection 2Q4
n=136 participants at risk
Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
|
Intravitreal Aflibercept Injection 2Q8
n=135 participants at risk
Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).
|
Macular Laser Photocoagulation (Control)
n=133 participants at risk
Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks. During year 3 laser patients could receive IAI as needed (PRN) .
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
4.4%
6/136 • Number of events 6 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
2.2%
3/135 • Number of events 3 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
6.0%
8/133 • Number of events 8 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Eye disorders
Cataract
|
22.8%
31/136 • Number of events 43 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
19.3%
26/135 • Number of events 37 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
12.8%
17/133 • Number of events 29 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Eye disorders
Cataract cortical
|
5.1%
7/136 • Number of events 12 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
4.4%
6/135 • Number of events 7 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.75%
1/133 • Number of events 3 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Eye disorders
Cataract subcapsular
|
8.1%
11/136 • Number of events 16 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
3.7%
5/135 • Number of events 6 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
3.0%
4/133 • Number of events 4 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Eye disorders
Conjunctival haemorrhage
|
31.6%
43/136 • Number of events 59 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
28.9%
39/135 • Number of events 58 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
12.8%
17/133 • Number of events 26 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Eye disorders
Conjunctival hyperaemia
|
5.9%
8/136 • Number of events 10 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
2.2%
3/135 • Number of events 5 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
6.8%
9/133 • Number of events 15 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Eye disorders
Corneal erosion
|
6.6%
9/136 • Number of events 11 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
5.9%
8/135 • Number of events 10 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
5.3%
7/133 • Number of events 16 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Eye disorders
Cystoid macular oedema
|
7.4%
10/136 • Number of events 18 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
14.8%
20/135 • Number of events 67 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
13.5%
18/133 • Number of events 51 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Eye disorders
Diabetic retinal oedema
|
24.3%
33/136 • Number of events 49 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
17.0%
23/135 • Number of events 44 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
13.5%
18/133 • Number of events 25 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Eye disorders
Eye pain
|
11.0%
15/136 • Number of events 34 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
7.4%
10/135 • Number of events 19 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
7.5%
10/133 • Number of events 15 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Eye disorders
Macular fibrosis
|
7.4%
10/136 • Number of events 13 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
8.9%
12/135 • Number of events 17 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
8.3%
11/133 • Number of events 14 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Eye disorders
Macular oedema
|
15.4%
21/136 • Number of events 41 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
14.8%
20/135 • Number of events 31 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
16.5%
22/133 • Number of events 46 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Eye disorders
Ocular hyperaemia
|
3.7%
5/136 • Number of events 12 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
5.2%
7/135 • Number of events 9 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
3.0%
4/133 • Number of events 5 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Eye disorders
Ocular hypertension
|
7.4%
10/136 • Number of events 21 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
3.0%
4/135 • Number of events 9 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
4.5%
6/133 • Number of events 7 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Eye disorders
Posterior capsule opacification
|
7.4%
10/136 • Number of events 15 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
8.9%
12/135 • Number of events 15 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
7.5%
10/133 • Number of events 18 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Eye disorders
Punctate keratitis
|
5.1%
7/136 • Number of events 13 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
8.1%
11/135 • Number of events 19 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
6.0%
8/133 • Number of events 14 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Eye disorders
Retinal aneurysm
|
10.3%
14/136 • Number of events 26 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
8.9%
12/135 • Number of events 26 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
6.8%
9/133 • Number of events 16 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Eye disorders
Retinal exudates
|
14.7%
20/136 • Number of events 38 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
16.3%
22/135 • Number of events 49 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
11.3%
15/133 • Number of events 32 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Eye disorders
Retinal haemorrhage
|
15.4%
21/136 • Number of events 35 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
18.5%
25/135 • Number of events 64 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
15.8%
21/133 • Number of events 63 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Eye disorders
Retinal vascular disorder
|
6.6%
9/136 • Number of events 20 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
5.9%
8/135 • Number of events 13 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
3.8%
5/133 • Number of events 10 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Eye disorders
Visual acuity reduced
|
24.3%
33/136 • Number of events 64 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
24.4%
33/135 • Number of events 81 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
22.6%
30/133 • Number of events 57 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Eye disorders
Vitreous detachment
|
6.6%
9/136 • Number of events 12 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
7.4%
10/135 • Number of events 11 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
3.8%
5/133 • Number of events 7 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Eye disorders
Vitreous floaters
|
9.6%
13/136 • Number of events 14 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
3.7%
5/135 • Number of events 7 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
3.0%
4/133 • Number of events 4 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Eye disorders
Vitreous haemorrhage
|
5.1%
7/136 • Number of events 14 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
8.1%
11/135 • Number of events 11 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
6.0%
8/133 • Number of events 12 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Infections and infestations
Bronchitis
|
8.8%
12/136 • Number of events 16 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
3.7%
5/135 • Number of events 5 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
6.8%
9/133 • Number of events 10 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Infections and infestations
Conjunctivitis
|
10.3%
14/136 • Number of events 16 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
9.6%
13/135 • Number of events 20 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
6.0%
8/133 • Number of events 10 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Infections and infestations
Influenza
|
5.1%
7/136 • Number of events 10 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
8.1%
11/135 • Number of events 11 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
9.8%
13/133 • Number of events 16 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Infections and infestations
Nasopharyngitis
|
27.9%
38/136 • Number of events 67 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
28.9%
39/135 • Number of events 69 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
25.6%
34/133 • Number of events 62 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Infections and infestations
Urinary tract infection
|
4.4%
6/136 • Number of events 8 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
8.1%
11/135 • Number of events 22 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
4.5%
6/133 • Number of events 11 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Investigations
Blood creatinine increased
|
5.1%
7/136 • Number of events 8 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
4.4%
6/135 • Number of events 6 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
3.8%
5/133 • Number of events 5 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Investigations
Blood glucose increased
|
7.4%
10/136 • Number of events 13 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
5.2%
7/135 • Number of events 8 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
6.0%
8/133 • Number of events 10 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Investigations
Blood urea increased
|
4.4%
6/136 • Number of events 8 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
7.4%
10/135 • Number of events 10 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
4.5%
6/133 • Number of events 7 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Investigations
Glycosylated haemoglobin increased
|
8.8%
12/136 • Number of events 15 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
8.1%
11/135 • Number of events 12 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
8.3%
11/133 • Number of events 11 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Investigations
Intraocular pressure increased
|
20.6%
28/136 • Number of events 77 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
13.3%
18/135 • Number of events 51 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
12.0%
16/133 • Number of events 32 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Investigations
Visual acuity tests abnormal
|
14.0%
19/136 • Number of events 35 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
16.3%
22/135 • Number of events 63 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
24.1%
32/133 • Number of events 49 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
4.4%
6/136 • Number of events 6 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
7.4%
10/135 • Number of events 12 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
6.8%
9/133 • Number of events 10 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.9%
4/136 • Number of events 5 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
2.2%
3/135 • Number of events 3 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
8.3%
11/133 • Number of events 11 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.74%
1/136 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
6.7%
9/135 • Number of events 9 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
0.75%
1/133 • Number of events 1 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.1%
7/136 • Number of events 10 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
4.4%
6/135 • Number of events 6 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
5.3%
7/133 • Number of events 10 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Vascular disorders
Hypertension
|
16.9%
23/136 • Number of events 32 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
18.5%
25/135 • Number of events 37 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
18.0%
24/133 • Number of events 41 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
|
Eye disorders
Dry eye
|
3.7%
5/136 • Number of events 9 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
3.7%
5/135 • Number of events 7 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
6.0%
8/133 • Number of events 13 • For each subject from his first study drug injection until 30 days after the last study drug injection at the latest up to termination visit at Week 148
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee CONTRACT PARTNERS shall provide to BSP (Bayer Schering Pharma) any proposed publication or oral at least sixty (60) days prior to the intended submission or presentation. If BSP does not notify CONTRACT PARTNERS within sixty (60) days of BSP's receipt of the intended PUBLICATION, CONTRACT PARTNERS shall be free to publish. CONTRACT PARTNERS acknowledge that in case of multi-centre studies the RESULTS of the STUDY are to be published only through coordination by Bayer.
- Publication restrictions are in place
Restriction type: OTHER